Status:
COMPLETED
Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Diseases
Eligibility:
All Genders
Phase:
NA
Brief Summary
Primary Outcome Measures:Incidence density of colonization with MRSA or VRE (number of new colonization events per 1000 patient days at risk) during the intervention phase. Secondary Outcome Measures:...
Detailed Description
This study will determine if rates of colonization and infection with 2 resistant Gram positive bacteria-methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE) a...
Eligibility Criteria
Inclusion
- ICUs that meet all of the following criteria are eligible to participate in the study:
- Adult medical, surgical, or medical/surgical ICU, meeting the following descriptions:
- Medical ICU-\>=80% of patients have medical conditions and have not undergone a surgical procedure during their hospital stay (patients weaned from mechanical ventilation may be included); Surgical ICU-\>=80% of patients have undergone a surgical procedure during their hospital stay (thoracic, cardiovascular, abdominal, orthopedic, neurosurgical, transplant, urologic, and trauma surgery procedures may be included); and Medical/surgical ICU-a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during their hospitalization (i.e., each group constitutes more than 20% and less than 80% of the total number of patients).
- Patient volume of \>=1200 patient days/6 months or \>=2400 patient days/12 months during 2002, 2003, or 2004;
- Incidence density of colonization of \>=9 colonization events with either MRSA or VRE/1000 ICU patient days based on results of clinical cultures during 2002, 2003, or 2004;
- Ability to collect the data required for the analysis;
- Written approval of the study from the institution's IRB; and
- Signed protocol signature page indicating willingness to enroll ICU in the study from the ICU physician and the ICU nursing directors.
Exclusion
- Intensive care units that meet any of the following criteria are excluded from the study:
- Coronary care, burn, bone marrow/hematopoetic stem cell transplant, neurosurgical, pediatric, or neonatal ICUs;
- ICUs currently screening all patients for colonization with MRSA and VRE on admission to the ICU and at least once a week during their ICU stay with results of surveillance cultures reported to clinicians (Note: ICUs screening only selected, "high-risk" patients, screening patients on admission to the ICU but not an ongoing basis, or screening patients for MRSA or VRE but not both MRSA and VRE are not excluded);
- ICUs currently with a policy for Universal Gloving for all patient contact regardless of whether the patient is known to be colonized with VRE or MRSA;
- ICUs planning to enroll subjects in studies testing investigational agents administered for the purpose of eradicating or preventing colonization with MRSA or VRE or devices or practice management strategies that have colonization and/or infection with resistant organisms as an outcome.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
30000 Patients enrolled
Trial Details
Trial ID
NCT00100386
Start Date
March 1 2005
End Date
August 1 2006
Last Update
June 10 2011
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
3
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5023
4
Yale University
New Haven, Connecticut, United States, 06510